Prosthetic Heart Valve And Systems And Methods For Delivering The Same

ABSTRACT

A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/864,035, filed on Sep. 24, 2015, which is a continuation under 35 USCSection 120 of International Application No. PCT/US2014/058826, filedOct. 2, 2014, entitled “Prosthetic Heart Valve and Systems and Methodsfor Delivering the Same,” which claims priority to and the benefit ofU.S. Provisional Patent Application Ser. No. 61/896,574, filed Oct. 28,2013, entitled “Improved Anterior Leaflet Clip Device for ProstheticMitral Valves” and U.S. Provisional Patent Application Ser. No.62/049,662, filed Sep. 12, 2014, entitled “Improved Anterior LeafletClip Device for Prosthetic Mitral Valves,” each of the disclosures ofwhich is hereby incorporated by reference in its entirety.

U.S. application Ser. No. 14/864,035 is also a continuation-in-part ofU.S. patent application Ser. No. 14/154,546, filed Jan. 14, 2014,entitled “Anterior Leaflet Clip Device for Prosthetic Mitral Valve,”which claims priority to and the benefit of U.S. Provisional PatentApplication Ser. No. 61/807,695, filed Apr. 2, 2013, entitled “AnteriorLeaflet Clip Device for Prosthetic Mitral Valve,” each of thedisclosures of which is hereby incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION

Embodiments described herein relate generally to prosthetic heartvalves, and apparatus, systems, and methods for delivering a prostheticdevice into a heart. More particularly, embodiments described hereinrelate to apparatus, systems, and methods for implanting andmanipulating a prosthetic heart valve and associated components into theheart.

The human heart is responsible for pumping blood around the human body.The human heart is separated into four distinct chambers, and iscommonly referenced in terms of the right or left side of the heart. Theright side of the heart, including the right atrium and the rightventricle, is responsible for receiving de-oxygenated blood from thebody, and then pumping the de-oxygenated blood to the lungs in order tooxygenate the blood. The left side of the heart, including the leftatrium and left ventricle, is responsible for receiving oxygenated bloodfrom the lungs, and then pumping the oxygenated blood to various partsof the body. The movement of blood within the chambers of the heart iscontrolled by four valves: aortic, mitral, pulmonic and tricuspid. Thesevalves open and close constantly, and as such, can be subject to wearand tear and other challenges that affect their performance (e.g.,mitral valve regurgitation, prolapse, and/or stenosis), andconsequently, the entire circulatory system.

Some known devices for repairing the performance of the heart, such as,for example, the performance of a mitral valve of the heart, can includea prosthetic heart valve. The prosthetic heart valve can be implantedand secured to a native annulus of the heart. In such cases, nativeleaflets of the heart valve can become disposed between the prostheticheart valve and the myocardium of the heart. Further, when the nativevalve leaflets are disposed in such a manner, the native valve leafletscan, for example, interfere with blood flow into and out of the leftventricle of the heart (e.g., interfere with left ventricular outflowtract (LVOT), reduction of effective orifice area (EOA) through theprosthetic heart valve). In some cases, this can occur when the nativevalve leaflets become at least partially disposed in the flow pathdefined through the orifice area of the prosthetic heart valve and fromthe atrium to the ventricle of the heart. In addition, over time, thenative valve leaflets can stiffen (e.g., change modulus) due tocalcification or the like, resulting in undesirable turbulence, eddies,and/or otherwise undesirable flow profiles within the heart. Even more,such degradation and/or stiffening of the native valve leaflets can, insome cases, cause degradation of the prosthetic heart valve leaflets.

Accordingly, there is a need for improved devices, systems and methodsfor securing, capturing, controlling, or otherwise manipulating nativevalve leaflets of a heart valve when a prosthetic heart valve isdisposed and operating therein.

BRIEF SUMMARY OF THE INVENTION

Apparatus, systems and methods for securing, capturing, controlling, orotherwise manipulating native heart valve leaflets when a prostheticheart valve is delivered to, or disposed in, a native annulus of anatrioventricular valve of a heart are described herein. In someembodiments, a prosthetic heart valve includes a self-expanding wireframe body, a valve disposed in the body, a leaflet clip coupled to thebody, and a control element operably coupled to the leaflet clip. Thebody has a proximal end and a distal end. The leaflet clip is configuredto be transitioned between a first configuration in which the prostheticvalve can be inserted into a heart, and a second configuration in whichthe leaflet clip is disposed to capture a native valve leaflet betweenthe leaflet clip and the wire frame body when the body is disposed in anative annulus of an atrioventricular valve of a heart. The controlelement has a length sufficient to extend from the leaflet clip througha ventricle of the heart and out a wall of the ventricle when the bodyis disposed in the native annulus of the atrioventricular valve of theheart. The control element is configured to allow a user to transitionthe leaflet clip from its first configuration to its secondconfiguration when the body is disposed in the native annulus of theatrioventricular valve of the heart.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a prosthetic heart valve accordingto an embodiment.

FIGS. 2a-2c show a prosthetic heart valve in a first position, secondposition and third position, respectively, according to an embodiment.

FIGS. 3 and 4 show prosthetic heart valve leaflet clips having a singlepoint of rotation and two points of rotation, respectively, in variouspositions.

FIG. 5 shows a prosthetic heart valve body in a rolled configurationaccording to an embodiment.

FIG. 6 shows the prosthetic heart valve body of FIG. 5 in a flattenedconfiguration according to an embodiment.

FIG. 7 shows a prosthetic heart valve system including the valve body ofFIGS. 5 and 6, according to an embodiment.

FIGS. 8a-10b show prosthetic heart valve leaflet clips in a firstconfiguration (FIGS. 8a, 9a, 10a ) and in a second configuration (FIGS.8b, 9b, 10b ) according to an embodiment.

FIGS. 11-13 show various prosthetic heart valve leaflet clips accordingto an embodiment.

FIG. 14 shows a prosthetic heart valve leaflet clip in a flattenedconfiguration according to an embodiment.

FIGS. 15-18 show a prosthetic heart valve in side view, in front view,in detailed view, and in perspective view, respectively, according to anembodiment.

FIG. 19 shows a prosthetic heart valve according to an embodiment.

FIGS. 20a and 20b show a prosthetic heart valve and sectional top viewof the same, according to an embodiment.

FIGS. 21a and 21b show a prosthetic heart valve and a section top viewof the same, according to an embodiment.

FIGS. 22a-23b show a prosthetic heart valve in a first configuration, asection top view of the same, the prosthetic heart valve in a secondconfiguration, and a sectional top view of the same, respectively,according to an embodiment.

FIG. 24 shows a prosthetic heart valve according to an embodiment.

FIGS. 25a and 25b show an elongate member in cross-section, and acontrol element and mandrel coupled thereto, and a top view of theelongate member, respectively, of the prosthetic heart valve of FIG. 24,according to an embodiment.

FIGS. 26a-d show a mandrel coupled to a control element, a tubularmember in top and side views, and a tubular member with a mandreldisposed therein, of the prosthetic heart valve of FIG. 24, according toan embodiment.

FIG. 27 shows a leaflet clip retrieval member according to an embodiment

FIGS. 28 and 29 show a prosthetic heart valve in a first configurationand a second configuration, respectively, according to an embodiment.

FIGS. 30 and 31 show a prosthetic heart valve in a first configurationand a second configuration, respectively, according to an embodiment.

FIGS. 32a and 32b shows the prosthetic heart valve of FIGS. 30 and 31,and a detailed view of the same, respectively, according to anotherembodiment.

FIGS. 33a -34 show a prosthetic heart valve in a first configuration, asecond configuration, and in a detailed view, respectively, according toan embodiment.

DETAILED DESCRIPTION

Apparatus, systems, and methods for securing, controlling, capturing, orotherwise manipulating native heart valve leaflets when a prostheticheart valve is delivered to or disposed in a native annulus of anatrioventricular valve of a heart are described herein

In some embodiments, a prosthetic heart valve (also referred to hereinas a “prosthetic valve”) includes a self-expanding wire frame body (alsoreferred to herein as a “body”), a valve disposed in the body, a leafletclip coupled to the body, and a control element operably coupled to theleaflet clip. The body has a proximal end and a distal end. The leafletclip is configured to be transitioned between a first configuration inwhich the prosthetic valve can be inserted into a heart, and a secondconfiguration in which the leaflet clip is disposed to capture a nativevalve leaflet between the leaflet clip and the wire frame body when thebody is disposed in a native annulus of an atrioventricular valve of aheart. The control element has a length sufficient to extend from theleaflet clip through a ventricle of the heart and out a wall of theventricle when the body is disposed in the native annulus of theatrioventricular valve of the heart. The control element is configuredto allow a user to transition the leaflet clip from its firstconfiguration to its second configuration when the body is disposed inthe native annulus of the atrioventricular valve of the heart.

In some embodiments, a method includes delivering to a native annulus ofan atrioventricular valve of a heart a prosthetic valve having aself-expanding body having a proximal end and a distal end. A valve isdisposed in the body and a leaflet clip is coupled to the body. Theleaflet clip is movable between a first configuration and a secondconfiguration, and a control element is operably coupled to the leafletclip. The leaflet clip and the control element are disposed on aventricular side of the native annulus. The leaflet clip is disposed inthe first configuration, and the body is allowed to self-expand intoengagement with the native annulus. A portion of the control element isdisposed outside the heart, and with the control element, tension isreleased to allow the leaflet clip to transition between the firstconfiguration and the second configuration to capture a native valveleaflet between the leaflet clip and the body.

In some embodiments, a system includes a prosthetic heart valve body, aleaflet clip, a control element operably coupled to the leaflet clip,and an elongate member. The body has a proximal end and a distal end.The leaflet clip is configured to be transition between a firstconfiguration during deployment of the body, and a second configuration,in which the leaflet clip captures a native valve leaflet between theleaflet clip and the body when the body is disposed in a native annulusof an atrioventricular valve of a heart. The control element has alength sufficient to extend from the leaflet clip through the ventricleof the heart and out a wall of the ventricle when the body is disposedin the native annulus of the atrioventricular valve of the heart. Thecontrol element is configured to allow a user to transition the leafletclip from its first configuration to its second configuration when thebody is disposed in the native annulus of the atrioventricular valve ofthe heart. The elongate member has a first end and a second end. Thefirst end is configured to be disposed in the ventricle of the heartduring deployment of the body and the second end is configured to extendoutside the heart. The elongate member defines a control element lumen.The control element is disposable in the control element lumen andextendable out the second end of the elongate member.

In some embodiments, a system for delivering a prosthetic heart valve toa native valve annulus includes a self-expanding wire frame body, aleaflet clip, an elongate member, and a control element. The body has aproximal end and a distal end. The elongate member has a first end and asecond end. The first end of the elongate member is configured to bedisposed in a ventricle of a heart during deployment of the prostheticheart valve, and the second end of the elongate member is configured toextend outside the heart. The elongate member defines a control elementlumen. The control element has a first end and a second end disposed inthe control element lumen and operably coupled to the leaflet clip. Thecontrol element has a length sufficient to extend from the leaflet clipthrough the control element lumen and out a wall of the ventricle whenthe body is disposed in the native annulus of the atrioventricular valveof the heart. The control element is configured to allow a user tomaintain the leaflet clip in a first configuration during deployment ofthe body, and to allow the user to transition the leaflet clip to asecond configuration, in which the leaflet clip captures a native valveleaflet between the leaflet clip and the body when the body is disposedin the native annulus of the atrioventricular valve of the heart.

As used herein, the singular forms “a,” “an”, and “the” include pluralreferents unless the context clearly dictates otherwise. Thus, forexample, the term “a member” is intended to mean a single member or acombination of members, “a material” is intended to mean one or morematerials, or a combination thereof.

As used herein, the words “distal” and “proximal” refer to a directionclose to and away from, respectively, an operator of, for example, amedical device. Thus, for example, the end of the medical device closestto the patient's body (e.g., contacting the patient's body or disposedwithin the patient's body) would be the proximal end of the medicaldevice, while the end opposite the proximal end and closest to, forexample, the user (or hand of the user) of the medical device, would bethe distal end of the medical device.

As used herein, the terms “about” and “approximately” generally meanplus or minus 10% of the value stated. For example, about 0.5 wouldinclude 0.45 and 0.55, about 10 would include 9 to 11, about 1000 wouldinclude 900 to 1100.

As described herein, when a prosthetic heart valve is implanted andsecured to a native heart valve annulus, native valve leaflets canbecome disposed between the prosthetic heart valve and the myocardium ofthe heart. When the native valve leaflets are disposed in such a manner,the native valve leaflets can, for example, interfere with operation ofthe prosthetic heart valve and/or with blood flow through the heart. Forexample, the native leaflets can obstruct the left ventricular outflowtract (LVOT), thereby reducing the flow of oxygenated blood to the body.The native leaflets can also obstruct the prosthetic heart valve andreduce the effective orifice area (EOA), thereby reducing the flow ofblood from the atrium to the ventricle. Furthermore, the native valveleaflets can interfere with proper seating of the prosthetic heart valvein the native valve annulus resulting in improper operation of theprosthetic heart valve. Said another way, if the prosthetic heart valvebody does not form a sufficient seal with the native valve annulus,blood can leak around the valve body and the prosthetic heart valve maynot function properly.

In some embodiments, a prosthetic heart valve can include a leafletclip. In use, i.e., during an operation in which the prosthetic heartvalve is delivered to a native annulus of an atrioventricular valve of aheart (e.g., mitral valve or a tricuspid valve), the leaflet clip canfunction to capture (e.g., grab, couple to, connect with, bias, pierce,enclose, etc.) a native valve leaflet. For example, when the prostheticheart valve is implanted into the native annulus of the heart, theleaflet clip can capture the native valve leaflet such that the nativeleaflet is disposed between the leaflet clip and a body portion of theprosthetic valve. In this manner, the native leaflet can be selectivelypositioned, for example, outside of the flow path between the prostheticheart valve orifice, thereby preserving the EOA of the prosthetic heartvalve, limiting and/or reducing LVOT obstruction, blood flow turbulence,eddies, or similar interference by the native leaflet during operationof the prosthetic heart valve. Similarly, over time as the nativeleaflet stiffens, due to calcification for example, or otherwise changesform, the leaflet clip can retain the native leaflet in a desirableposition such that a desirable blood flow profile is maintained.Further, the native leaflet can be selectively positioned and/orenclosed by the leaflet clip to provide sealing between the prostheticheart valve (e.g., the body of the prosthetic heart valve) and thenative annulus of the heart valve, and additionally as a result, betweenthe left ventricle of the heart and the left atrium of the heart.

As described in further detail herein, in some embodiments, theprosthetic heart valve and/or the leaflet clip can be operably coupledto a control element that is configured to allow a user to transitionthe leaflet clip to capture the native leaflet between the a bodyportion of the prosthetic heart valve and the leaflet clip.

FIG. 1 is a schematic illustration of a prosthetic heart valve system1000. The prosthetic heart valve 1000 is designed to be disposed in adamaged or diseased native heart valve such as a mitral valve. Theprosthetic heart valve 1000 (also referred to herein as a “prostheticvalve”) includes a prosthetic valve body 1100, a first leaflet clip 1200a, and optionally a second leaflet clip 1200 b (referred to collectivelyas “clips 1200”). In some embodiments, additional leaflet clips 1200 canbe included in the prosthetic heart valve 1000. The leaflet clips 1200are coupled to the prosthetic valve body 1100 and are configured to betransitioned between a first configuration in which the prosthetic valve1000 can be inserted into a heart, and a second configuration in whichthe leaflet clips 1200 are disposed to capture one or more native valveleaflets between the leaflet clips 1200 and the valve body 1100 when thevalve body 1100 is disposed in a native annulus of an atrioventricularvalve of a heart. A control element 1300 is operably coupled to theleaflet clips 1200 and has a length sufficient to extend from theleaflet clips 1200 through a ventricle of the heart and out a wall ofthe ventricle when the valve body 1100 is disposed in the native annulusof the atrioventricular valve of the heart. The control element 1300 isfurther configured to allow a user to transition the leaflet clips 1200from their first configuration to their second configuration (eitherindividually or simultaneously) when the valve body 1100 is disposed inthe native annulus of the atrioventricular valve of the heart.

The prosthetic valve body 1100 can be formed such that it can bedeformed (e.g., compressed and/or expanded) and, when released, returnto its original (undeformed) size and shape. To achieve this, the valvebody 1100 can be formed of any suitable material, or combination ofmaterials, such as metals or plastics that have shape memory properties.In some embodiments, the valve body 1100 can be formed from Nitinol.Other shape memory alloys, such as, for example, Cu—Zn—Al alloys and/orCu—Al—Ni alloys can be used. The prosthetic valve body 1100 can be thesame as or similar to any of the prosthetic valves described inInternational Patent Application No. PCT/US14/44047, entitled “ThrombusManagement and Structural Compliance Features for Prosthetic HeartValves,” (“the '047 application”), and International Patent ApplicationNo. PCT/US14/40188, entitled “Structure Members for Prosthetic MitralValves,” (“the 188 application”), the disclosures of which areincorporated herein by reference in their entirety.

The valve body 1100 includes a valve (not shown) disposed therein. Thevalve body 1100 can be any suitable size, shape, or configuration. Insome embodiments, the valve body 1100 can include an outer frame, and aninner valve assembly that includes an inner frame and leaflets. Further,in some embodiments, the valve body 1100 can have an upper, proximal end(e.g., at an atrium portion), a lower, distal end (e.g., at a ventricleportion), and a medial portion (e.g., at an annulus portion)therebetween. The medial portion, in such embodiments, can have aperimeter that is configured to fit into an annulus of a nativeatrioventricular valve (e.g., a mitral valve or a tricuspid valve). Theupper end of the outer frame can have a perimeter that is larger thanthe perimeter of the medial portion. As will be shown in furtherembodiments, portions of the valve body 1100 can have a D-shapedcross-section (e.g., the upper end and the medial portion of the outerframe). In this manner, the outer frame can promote a suitable fit intothe annulus of the native atrioventricular valve.

As described herein, the leaflet clips 1200 are operably coupled to thevalve body 1100. The leaflet clips 1200 can be coupled to the valve body1100 in any suitable manner. In some embodiments, the leaflet clips 1200and the valve body 1100 can be monolithically constructed. In otherembodiments, the leaflet clips 1200 and the valve body 1100 can beformed separately and then joined together (e.g., using a wire, a screw,an interference fit, a weld, or otherwise any suitable fastener orfastening method). In some embodiments, the leaflet clips 1200 can besubstantially permanently coupled to the valve body 1100, while in otherembodiments, the leaflet clips 1200 can be removably coupled to thevalve body 1100.

In some embodiments, the leaflet clips 1200 can be coupled to or a partof an outer frame of the valve body 1100, while in other embodiments,the leaflet clips 1200 can be coupled to or a part of an inner frame ofthe valve body 1100. Moreover, the leaflet clips 1200 can be coupled tothe valve body 1100 at any suitable time. For example, the leaflet clips1200 can be coupled to the valve body 1100 before delivery of prostheticheart valve 1000 into a heart, i.e., the leaflet clips 1200 can becoupled to the valve body 1100 when the heart valve 1000 is disposedoutside the heart. As another example, the leaflet clips 1200 can becoupled to the valve body 1100 after the prosthetic heart valve 1000 isdisposed inside the heart. In this manner, the valve body 1100 and theleaflet clips 1200 can be delivered to the heart separately, and coupledto one another after both the valve body 1000 and the leaflet clips 1200are disposed in the heart.

In some embodiments, the first leaflet clip 1200 a can include a firstleaflet covering 1210 a disposed on at least a portion of the firstleaflet clip 1200 a. Similarly, in some embodiments, the second leafletclip 1200 b can include a second leaflet covering 1210 b disposed on atleast a portion of the second leaflet clip 1200 b. The covering 1210 aand the covering 1210 b (referred to collectively as “coverings 1210”)can be constructed from any suitable material, or any combination ofmaterials such as, for example, stabilized tissue derived from 30 dayold bovine, ovine, equine or porcine pericardium, or from animal smallintestine submucosa. In some embodiments, the coverings 1210 can beconstructed from a synthetic material including, for example, polyester,polyurethane, polytetrafluoroethylene, or a combination thereof. In use,the coverings 1210 can enhance the ability to capture, secure, bias, orotherwise contain or manipulate a native valve leaflet. For example, inuse, the coverings 1210 can provide an enhanced surface area configuredto at least partially enclose a native leaflet, thereby enhancingmanagement and/or selective control of the native leaflet. In thismanner, the coverings 1210 can prevent at least a portion of one or morenative leaflets from protruding through an area defined by the leafletclips 1200, thereby limiting and/or reducing the potential undesirableinterference of the one or more native valve leaflets with blood flow,LVOT, EOA, or otherwise proper functioning of the heart and/or theprosthetic heart valve 1000. Moreover, in some embodiments the coverings1210 can be configured to promote or accelerate desirable in-growthbetween the coverings 1210 and/or the valve body 1100, and the nativeleaflets.

In some embodiments, the coverings 1210 can substantially cover theleaflet clips 1200 (e.g., substantially the entire area defined by theleaflet clips 1200). In other embodiments, the coverings 1210 can definean aperture, or multiple apertures, to allow blood to flow there-through(e.g., from the atrium to the ventricle during delivery of theprosthetic valve 1000, during deployment of the valve body 1100, and/orduring manipulation of the leaflet clips 1200). In this manner, in use,an aperture of the coverings 1210 can be configured to limit and/orreduce blood flow restriction, and enhance movement and manipulation ofthe leaflet clips 1200 and/or the valve body 1100. Further to thisexample, in use, the coverings 1210 can be configured to allow bloodflow there-through when the leaflet clips 1200 are in a disengaged(i.e., disengaged with respect to a native leaflet; in a “ready state”).Such a configuration can limit and/or prevent undesirable interruptionof blood flow (e.g., LVOT obstruction) during delivery and deployment ofthe prosthetic heart valve 1000 and the leaflet clips 1200. Theaperture(s) can be sized and/or shaped in any suitable manner, e.g., toencourage a desirable flow rate there-through. As described herein, insome embodiments, the coverings 1210 can include multiple materialsand/or configurations. In this manner, the coverings 1210 can beconfigured to promote in-growth between the coverings 1210 and/or thevalve body 1100, and the native leaflets. For example, the coverings1210 can include varying porosities configured to promote in-growthand/or allow blood to flow through the varying porosities at varyingflow rates.

The leaflet clips 1200 can be any shape, size or configuration, and canbe formed of any suitable material, or combination of materials. In someembodiments, similar to the valve body 1100 in some instances, theleaflet clips 1200 can be formed such that they can be deformed (e.g.,compressed, expanded, reconfigured, or otherwise biased in some manner),and when released, return to their original sizes, shapes and/orconfigurations (undeformed).

In some embodiments, the leaflet clips 1200 can be substantiallyidentical to each other in shape, size, and/or configuration, while inother embodiments, the leaflet clips 1200 can be different than oneanother in shape, size, and/or configuration. Various configurations ofthe leaflet clips 1200 will be discussed in further detail herein, andillustrated in more detail in further figures.

The leaflet clips 1200 can function to engage (e.g., capture, bias,couple to, connect with, pierce, enclose, etc.) one or more nativeleaflets of a heart valve. More specifically, the leaflet clips 1200 cancapture a native leaflet between the leaflet clips 1200 and the valvebody 1100. Any number of leaflet clips can be configured to capture anynumber of native valve leaflets, and at any location of the valve body1100, as discussed in further detail herein. In some embodiments, theleaflet clips 1200 (i.e., the leaflet clip 1200 a and the leaflet clip1200 b) can be configured to capture a single native valve leaflet. Inother embodiments, the leaflet clips 1200 can be configured to capturemultiple native leaflets. For example, the leaflet clip 1200 a can beconfigured to capture a native leaflet at an A2 portion (also referredto as “A2 leaflet”) of the heart valve, and the leaflet clip 1200 b canbe configured to capture a native leaflet at a P2 portion (also referredto as “P2 leaflet”) of the heart valve. Further to this example, in manyinstances the A2 leaflet has a size and shape different than the P2leaflet. In such instances, the first leaflet clip 1200 a can be sizedand/or shaped to sufficiently engage and capture the A2 leaflet.Similarly, the second leaflet clip 1200 b can be sized and/or shaped tosufficiently engaged and capture the P2 leaflet. In some embodiments,the leaflet clips 1200 can vary in width based on their configuration orposition. For example, the leaflet clips 1200 can have a first widthwhen disposed in a disengaged position, and a second width when disposedin an engaged configuration, where the second width is greater than thefirst width.

Moreover, in this manner, one or more native leaflets can be capturedand selectively positioned outside of the flow path defined between theprosthetic heart valve 1000 orifice (e.g., through the valve disposed inthe valve body 1100), thereby preventing obstruction or reduction of theEOA. Similarly, the leaflet clips 1200 and the valve body 1100 cancollectively function to position one or more native leaflets to providesealing between the prosthetic heart valve 1000 (e.g., an outer portionof the valve body 1100) and the native annulus of the atrioventricularvalve of the heart.

In some embodiments, a force can be applied to the leaflet clips 1200.In this manner, the leaflet clips 1200 can be disposed in a firstconfiguration based at least in part on the force. Further, in suchembodiments, the leaflet clips 1200 can be transitioned into a secondconfiguration based at least in part on reduction of the force.Similarly stated, the leaflet clips 1200 can be disposed in a firstconfiguration for a time period and when the force (e.g., tension) isbeing applied to the leaflet clips 1200. In such embodiments, theleaflet clips 1200 s can be transitioned from the first configuration toa second configuration after the time period and when the force isreduced or no longer applied (e.g., the tension is released). Further,in some embodiments, the leaflet clips 1200 can transition from thefirst configuration to the second configuration based on a force (e.g.,generated by a user), as previously discussed above, and alternativelyor additionally, the leaflet clips 1200 can transition from the firstconfiguration to the second configuration based on a material from whichthe leaflet clips 1200 are formed (e.g., a material having shape memoryproperties).

The leaflet clips 1200 can be operably coupled to the control element1300 (e.g., suture, tether, etc.) in any suitable manner. The controlelement 1300 can be configured to allow a user to transition the leafletclips 1200 from a first configuration (e.g., during delivery, disengagedfrom native leaflet) to a second configuration (e.g., engaged with thenative leaflet). For example, in some embodiments, the control element1300 can apply a force to the leaflet clips 1200 such that the leafletclips 1200 are disposed in the first configuration. Further to thisexample, in some embodiments, the first configuration can include theleaflet clips 1200 being disposed in a deformed state, e.g., ininstances where the leaflet clips 1200 are formed of shape memorymaterial. In such embodiments, the control element 1300 can reduce orremove the force to the leaflet clips 1200 such that the leaflet clips1200 transition from the first configuration to the secondconfiguration. The second configuration can include the leaflet clips1200 being disposed in an undeformed state, e.g., in instances where theleaflet clips 1200 are formed of shape memory material. In otherembodiments, the force applied by the control element 1300 can be afirst force, and the leaflet clips 1200 can transition from the firstconfiguration to the second configuration based at least in part on asecond force (e.g., a spring, hinge or the like coupled to the valvebody 1100 and operably coupled to the leaflet clips 1200). For example,the prosthetic valve 1000 can include leaflet clip attachment members(not shown) disposed between the leaflet clips 1200 and the valve body1100. The leaflet clip attachment members can transition the leafletclips 1200 from the first configuration to the second configuration. Forexample, the leaflet clip attachment members can include an energystorage member such as a spring-loaded hinge, a spring, or the like.Further to this example, instead of or in addition to shape memoryproperties of the leaflet clips 1200 causing the leaflet clips 1200 totransition from the first configuration to the second configuration, theenergy storage member can promote transition of the leaflet clips 1200from the first configuration to the second configuration.

In some embodiments, the leaflet clips 1200 can be removably coupled tothe control element 1300. In use, the control element 1300 can becoupled to the leaflet clips 1200 during delivery of the prostheticvalve 1000 to a native annulus of an atrioventricular valve of a heart,and during manipulation of the leaflet clips 1200, and selectivelydecoupled (e.g., by an operator) from the leaflet clips 1200 thereafter.

Although control element 1300 is shown in FIG. 1 as being operablycoupled to both leaflet clip 1200 a and leaflet clip 1200 b, in someembodiments, control element 1300 can include a first control element1300 a and a second control element 1300 b. In such embodiments, thefirst control element 1300 a and the second control element 1300 b canbe monolithically constructed, while in other embodiments, the firstcontrol element 1300 a and the second control element 1300 b can beformed separately, and in some cases, attached. In some embodiments, thefirst control element 1300 a can be operably coupled to the firstleaflet clip 1200 a and not the second leaflet clip 1200 b, and thesecond control element 1300 b can be operably coupled to the secondleaflet clip 1200 b and not the first leaflet clip 1200 a. In otherembodiments, the first control element 1300 a and the second controlelement 1300 b can each be operably coupled to both the first leafletclip 1200 a and the second leaflet clip 1200 b.

The first control element 1300 a and the second control element 1300 bcan be coupled to one another in any suitable manner (e.g., a knot, afastener, etc.) such that a user can operate both the first controlelement 1300 a and the second control element 1300 b substantiallysimultaneously, and as such, the user can manipulate both the firstleaflet clip 1200 a and the second leaflet clip 1200 b substantiallysimultaneously. In use, in some embodiments, the first control element1300 a can be coupled to the second control element 1300 b within theheart, while in other embodiments, the first control element 1300 a canbe coupled to the second control element 1300 b outside the heart.

In some embodiments, the first control element 1300 a and the secondcontrol element 1300 b can be configured such that a user canindependently operate the first control element 1300 a and the secondcontrol element 1300 b, and as such, the user can independentlymanipulate the first leaflet clip 1200 a and the second leaflet clip1200 b. In this manner, a user can transition first leaflet clip 1200 avia the first control element 1300 a from a disengaged configuration(e.g., in which the prosthetic valve can be inserted into the heart) toan engaged configuration (e.g., in which the first leaflet clip 1200 ais disposed to capture a native valve leaflet between the first leafletclip 1200 a and the valve body 1100). In a similar manner, a user cantransition the second leaflet clip 1200 b via the second control element1300 b from a disengaged configuration (e.g., in which the prostheticvalve can be inserted into the heart) to an engaged configuration (e.g.,in which the second leaflet clip 1200 b is disposed to capture a nativevalve leaflet between the second leaflet clip 1200 b and the valve body1100).

Moreover, the first leaflet clip 1200 a and the second leaflet clip 1200b can include a first control portion (not shown) and a second controlportion (not shown), respectively (referred to collectively as “controlportions”). The control portions 1230 can be configured to be coupled tothe control element 1300. In some embodiments, the control portions 1230can include an aperture, a ring, a loop, a slot, or otherwise anysuitable anchor point for the control element 1200 to attach to. In someembodiments, the control portions 1230 and the leaflet clips 1200 can bemonolithically constructed, while in other embodiments, the controlportions 1230 and the leaflet clips 1200 can be formed separately andthen joined together (e.g., using a wire, a weld, or otherwise anysuitable fastener or fastening method).

In some embodiments, the leaflet clips 1200 can be configured to notundesirably interfere with a portion of an atrioventricular valve of aheart. For example, the leaflet clips 1200 can be sized and shaped suchthat they do not undesirably interfere with a native annulus of theatrioventricular valve (e.g., when the leaflet clips 1200 are in anengaged configuration or in the process of transitioning into theengaged configuration). Further to this example, more specifically, theleaflet clips 1200 can have a first end and a second end having a lengththat is less than a length of the valve body 1100. As such, the leafletclips 1200 can be spaced a non-zero distance from the native annuluswhen the leaflet clips 1200 are in the engaged configuration. In thismanner, the leaflet clips 1200 can transition between various positionsand configurations without undesirably interfering with the nativeannulus, while having a length sufficient to capture one or more nativeleaflets. Similarly, the leaflet clips 1200 can be spaced a non-zerodistance from an internal surface of a ventricle (e.g., a ventricularwall) when the leaflet clips 1200 are in the disengaged configuration,engaged configuration, or any position there between. In this manner,the leaflet clips 1200 can transition between various positions andconfigurations without undesirably interfering with portions of theatrioventricular valve, such as, a ventricular wall.

FIGS. 2a-2c show a prosthetic valve 2000 according to an embodiment in afirst position (FIG. 2a ), a second position (FIG. 2b ), and a thirdposition (FIG. 2c ), respectively. The prosthetic valve 2000 includes avalve body 2100, a first leaflet clip 2200 a and a second leaflet clip2200 b (referred to collectively as “leaflet clips 2200”), an anchoringtether 2130, and a first control element 2300 a and a second controlelement 2300 b (referred to collectively as “control elements 2300”).The valve body 2100 has a proximal end 2110 and a distal end 2120, andincludes multiple self-expanding atrial anchoring elements distributedcircumferentially about, and extending radially outwardly from, theproximal end 2110 of the valve body 2100. In this embodiment, the valvebody 2100 and the leaflet clips 2200 are formed from a laser-cut tube ofNitinol. The anchoring tether 2130 is coupled to the distal end 2120 ofthe valve body 2100.

The leaflet clips 2200 are integrally formed with the valve body 2100.The first leaflet clip 2200 a and the second leaflet clip 2200 b includea first leaflet clip covering 2210 a and a second leaflet clip covering2210 b, respectively (referred to collectively as “coverings 2210”). Asdescribed above, the coverings 2210 can be constructed from any suitablematerial, or any combination of materials.

The anchoring tether 2130 is attached to the distal end 2120 of thevalve body 2100. Although not shown, the anchoring tether 2130 can havea length sufficient to extend from the distal end 2120 of the valve body2100 through the ventricle of a heart and out the wall of the ventriclewhen the valve body 2100 is disposed in a native annulus of anatrioventricular valve of the heart. The anchoring tether 2130 can beconfigured to anchor the prosthetic valve 2000 to the heart at alocation external to the heart.

As best shown in FIG. 2b , the control elements 2300 are operably andremovably coupled to the leaflet clips 2200. In this manner, the controlelements 2300 are configured to transfer a force to the leaflet clips2200 such that the leaflet clips 2200 transition among variouspositions. Further, the control elements 2300 are configured to allow auser to transition leaflet clips 2200 among the various positions.

In use, the leaflet clips 2200 can be transitioned between severaldifferent positions. For ease of illustration, in FIGS. 2a-2c , firstleaflet clip 2200 a and the second leaflet clip 2200 b are shown in likeor matching positions. It should be noted that, in some embodiments, thefirst leaflet clip 2200 a and the second leaflet clip 2200 b can betransitioned at different times between different positions. Forexample, the first leaflet clip 2200 a can be disposed in a firstposition when second leaflet clip 2200 b is disposed in a secondposition. In this manner, a user can manipulate each leaflet clipindependently such that the first leaflet clip 2200 a can capture anative leaflet at a first time, and the second leaflet clip 2200 b cancapture a native leaflet at a second time after the first time. Suchfunctionality allows for better, more repeatable capture and recaptureof native leaflets.

In the first position (FIG. 2a ), the leaflet clips 2200 are indisengaged positions (i.e., disengaged with respect to a native valveleaflet). Said another way, in the first position, the leaflet clips2200 are in a “ready state” (i.e., ready to capture a native valveleaflet between the leaflet clips 2200 and the valve body 2100).Further, in the first position, the leaflet clips 2200 are disposed suchthat the valve body 2100 can be inserted into a heart. In this manner,in use, as the valve body 2100 is delivered to a native annulus of anatrioventricular valve of a heart, the leaflet clips 2200 can limitand/or provide for minimal undesirable contact and/or interference withportions of the heart (e.g., native chordae tendineae of the heart).Further, in the first position, the leaflet clips 2200 are in theirdeformed positions, i.e., not in their at least partially predefined,undeformed positions, e.g., as defined in part by their shape memoryproperties. Moreover, as shown, a force (tension) is applied by thecontrol elements 2300 to the leaflet clips 2200. In this manner, thecontrol elements 2300 are configured to maintain the leaflet clips 2200in the first position.

To move the leaflet clips 2200 from the first position (FIG. 2a ) to thesecond position (FIG. 3), tension applied to the leaflet clips 2200 bythe control elements 2300 is partially released. As shown in FIG. 2b ,in the second position, the leaflet clips 2200 are in intermediatestates. Similarly stated, the leaflet clips 2200 are in partiallyengaged positions, i.e., in a position to contact a native valve leafletof the heart.

To move the leaflet clips 2200 from the second position (FIG. 2b ) tothe third position (FIG. 2c ), tension applied to the leaflet clips 2200by the control elements 2300 is released further. In the third position(FIG. 2c ), the leaflet clips 2200 are in fully engaged positions. Inthis manner, the leaflet clips 2200 are disposed to capture one or morenative valve leaflets (not shown) between the leaflet clips 2200 and thevalve body 2100 when the valve body 2100 is disposed in a native annulusof an atrioventricular valve of a heart (not shown). Thus, the leafletclips 2200 are configured to retain one or more native valve leafletswhen the leaflet clips 2200 are in the third position such that one ormore native valve leaflets do not undesirably interfere with flowthrough the valve body 2100 (e.g., through a prosthetic valve disposedin the valve body 2100).

Although the leaflet clips 2200 are shown as rotating and/or bendingabout an axis when transitioning between positions (FIGS. 2a-2c ), inother embodiments, the leaflet clips 2200 can be configured totransition between positions in any suitable manner to capture and/orbias one or more native valve leaflets. For example, the leaflet clips2200 can be configured to slide and/or otherwise translate betweenpositions (e.g., from the first position to the third position) tocapture one or more native valve leaflets.

Although the transition of the leaflet clips 2200 from the firstposition (disengaged; deformed) to the second position (intermediate;partially engaged and deformed) and to the third position (engaged,undeformed) has been described above as resulting at least in part froma release or reduction of tension via the control elements 2300, inother embodiments, leaflet clips 2200 can be transitioned betweenpositions in or by any suitable manner. For example, the leaflet clips2200 can be configured to transition from a disengaged, undeformedposition, to an engaged position, at least in part in response toreceiving a force from control elements 2300. In this manner, a forcecan be applied to the leaflet clips 2200 to cause the leaflet clips 2200to transition from their disengaged position to their engaged position(i.e., disposed to capture one or more native valve leaflets between theleaflet clips 2200 and the valve body 2100 when the valve body 2100 isdisposed in a native annulus of an atrioventricular valve of a heart).

In use, the force applied to and released from the leaflet clips 2200can be produced and released in any suitable manner, e.g., the force canbe produced and reduced manually by a user. For example, a user canapply or release tension at a distal end portion (not shown) of thecontrol elements 2300. Further to this example, the distal end portionof the control elements 2300 can be disposed outside the heart.

As described herein, the leaflet clips 2200 are configured to capturenative leaflets of a heart valve. In doing so, the leaflet clips 2200can be moved throughout the ventricle of a native heart valve. In someembodiments, the leaflet clips 2200 can be configured to limit or avoidundesirable interference with portions of the heart valve (e.g.,interference with the native chordae tendineae of the heart, or a wallof the heart), and to promote sufficient capture and/or containment ofone or more native leaflets. For example, the leaflet clips 2200 canhave one or more axis or points of rotation. In this manner, in use, asthe leaflet clips 2200 are transitioned through various positions withinthe heart, the leaflet clips 2200 can be maintained in profiles suitablefor avoidance of undesirable interference with portions of the nativeheart valve, and suitable for sufficient capture of one or more nativeleaflets.

Further to this example, as shown in FIGS. 3 and 4, the leaflet clips2200 can have a single point of rotation (FIG. 3) or two points ofrotation (FIG. 4), respectively. As shown in FIG. 3, the leaflet clip2200 can have a single point of rotation, i.e., rotation point 2240. Inuse, the leaflet clip 2200 can be transitioned between various positionsand configurations, shown by arrow A, by being rotated about therotation point 2240. Further, the leaflet clip 2200 can have distal enddisposed at a maximum distance D1 measured from that distal end to anaxis defined by an end of the valve body 2100 when the leaflet clip 2200is being transitioned from a disengaged configuration to an engagedconfiguration. As another example, as shown in FIG. 4, the leaflet clip2200 can have two points of rotation, i.e., a first point of rotation2240 and a second point of rotation 2250. In use, the leaflet clip 2200can be transitioned between various positions and configurations, shownby arrow B, by being rotated about the rotation point 2240 and therotation point 2250. Further to this example, the leaflet clip 2200 canhave a distal end disposed at a maximum distance D2 measured from thatdistal end to an axis defined by an end of the valve body 2100 when theleaflet clip 2200 is being transitioned from a disengaged configurationto an engaged configuration. As shown, distance D1 is greater thandistance D2. Thus, the additional rotation point, i.e., rotation point2250, can reduce or limit the leaflet clips 2200 profile, therebypromoting avoidance of undesirably interference with portions of thenative heart valve. In addition, the additional rotation point canpromote suitable capture of one or more native leaflets. Although theleaflet clip 2200 shown in FIG. 4 has only two rotation points, in someembodiments, the leaflet clip 2200 can have any suitable number rotationpoints (e.g., 3, 4, 5 or more).

FIGS. 5-7 show a valve body 3100 and leaflet clips 3200, of a prostheticheart valve 3000, in an undeformed, initial state, i.e., as laser-cut,and in a rolled configuration (FIG. 5), a flat sheet of the same forease of illustration (FIG. 6), and a side view with the leaflet clips3200 in an engaged position (FIG. 7), according to an embodiment. Asshown in FIG. 5, the leaflet clips 3200 and the valve body 3100 areformed and laser-cut from the same piece of Nitinol. As such, theleaflet clips 3200 are integral to the valve body 3100.

The prosthetic valve 3000 includes a first leaflet clip 3200 a and asecond leaflet clip 3200 b (referred to collectively as “leaflet clips3200”). The leaflet clips 3200 can be configured the same as or similarto the leaflet clips described in any other embodiments described herein(e.g., the leaflet clips 1200 and/or the leaflet clips 2200). Theleaflet clips 3200 can be any suitable shape, size, or configuration tocapture a native valve leaflet. The first leaflet clip 3200 a and thesecond leaflet clip 3200 b are configured to collectively capture anative valve leaflet (e.g., an A2 leaflet). The first leaflet clip 3200a includes a leaflet control portion 3230 a configured to operablycouple to a control element (not shown). Similarly, the second leafletclip 3200 b includes a leaflet control portion 3230 b configured tooperably couple to the control element (not shown). The leaflet controlportion 3230 a and the leaflet control portion 3230 b are referred tocollectively as “control portions 3230.” The leaflet control portions3230 each define an aperture. In some embodiments, the leaflet controlportions 3230 can define any suitable number of apertures, and in anysuitable size, shape or configuration.

Moreover, in some embodiments, control element (not shown) can include atether configured to be routed through the apertures defined by thecontrol portions 3230. In this manner, in use, the control element cancause the leaflet clips 3200 to transition between various positions(e.g., the same or similar positions discussed above with respect toprosthetic heart valve 2000).

Although the control portions 3230 each define an aperture, in otherembodiments, the control portions 3230 can be any suitable shape, size,or configuration. For example, the control portions 3230 can include aprotrusion, a fastener, a clasp, or the like, i.e., any suitable featureto allow for attachment of or control/manipulation by control element(e.g., a user of control element).

As best shown in FIG. 7, the first leaflet clip 3200 a and secondleaflet clip 3200 b are each disposed on a single side portion of thevalve body 3100, e.g., an A2 portion of the valve body 3100. In thismanner, the first leaflet clip 3200 a and second leaflet clip 3200 b canbe configured to capture a single native valve leaflet when prostheticheart valve 3000 is disposed in a native atrioventricular valve of aheart. The leaflet clips 3200 can include coverings (not shown) the sameas or similar to the coverings described above with respect to leafletclips 1210 and/or leaflet clips 2210.

Although many of the leaflet clips discussed herein are integral totheir respective valve bodies, in some embodiments, one or more leafletclips can be formed separately from a valve body, and then joinedtogether in any suitable manner (e.g., using any suitable fastener orfastening method, a screw, wire, an interference fit, laser welding,etc.). In addition, in some embodiments, one or more leaflet clips caninclude a pivot portion configured to provide an axis about which theclip can fold over and/or otherwise capture a native valve leaflet. Saidanother way, the pivot portion of the leaflet clip can delineate an axisacross the leaflet clip such that a portion of the leaflet clip disposedon one side of the axis is configured to contact a proximal portion ofthe native leaflet, and a portion of the leaflet clip disposed on theopposite side of the axis is configured to contact a distal portion ofthe native leaflet. In some embodiments, a leaflet clip can includemultiple points of rotation (e.g., two points of rotation).

In some embodiments, the leaflet clips described herein can include aclip attachment portion configured to allow the leaflet clip to becoupled to a valve body. For example, as shown in FIGS. 8a-10b , aleaflet clip 4200 defines a clip attachment portion 4250, a pivotportion 4260, and a leaflet control portion 4230. The leaflet clip 4200is configured to be coupled to the valve body 4100 at the clipattachment portion 4250. As shown in FIGS. 8a, 9a, and 10a , the leafletattachment portion 4250 defines multiple apertures configured to allowfor the leaflet clip 4200 to be coupled to the valve body 4100 in anysuitable manner (e.g., any suitable fastener, a screw, a wire, a tether,laser weld, etc.). The number of apertures defined by the leafletattachment portion 4250 in FIGS. 8a, 9a , and 10 a are illustrativeexamples. In other embodiments, any suitable number of apertures can bedefined and/or used.

In use, the leaflet clip 4200 is configured to capture a native valveleaflet. FIGS. 8a, 9a, and 10a show leaflet clip 4200 in a firstconfiguration (“ready state”, disengaged). FIGS. 8b, 9b, and 10b showthe leaflet clip 4200 in a second configuration (engaged), i.e.,disposed to capture native leaflet L between either end of the leafletclip 4200, the ends being defined in part by the pivot portion 4260.

Further shown in FIGS. 8a-10b are examples of various shapes, sizes, andconfigurations of the leaflet clip 4200. FIGS. 8a and 8b , for example,show the leaflet clip 4200 as having a fork-like shape, i.e., a shapehaving two prongs spaced apart in a suitable manner by a widthconfigured to promote suitable capturing of a native valve leaflet.Similarly, FIGS. 9a and 9b , show the leaflet clip 4200 as having asimilar two-prong structure, however, the prongs have a width largerthan a width of the prongs illustrated in FIGS. 8a and 8b . As anotherexample, FIGS. 10a and 10b show the leaflet clip 4200 as having aU-shape.

As described above, the leaflet clips can have any suitableconfiguration and can be disposed at any suitable location on the valvebody. For example, as shown in FIG. 11, the leaflet clip 5200 can besymmetrical with respect to an axis, i.e., axis A, defined by the valvebody 5100 of a prosthetic valve 5000. In some embodiments, as shown forexample in FIG. 12, the leaflet clip 5200 can be offset, i.e.,asymmetric with respect to axis A defined by the valve body 5100. Insome embodiments, such as the asymmetric configuration shown in FIG. 12,the leaflet clip 5200 can promote desirable capturing of a nativeleaflet. Further to this example, in use, an asymmetric configuration,i.e., asymmetric with respect to axis A, can be configured to disposethe leaflet clip 5200 in a substantially symmetric fashion with respectto a centerline axis of a native leaflet (not shown) when the valve body5100 is disposed in a native annulus of an atrioventricular valve of aheart. In this manner, the leaflet clip 5200 can be disposed at a radialposition of the valve body 5100 based at least in part on a location ofa target native valve leaflet so as to promote suitable capture and/orcontrol of the native valve leaflet.

FIG. 13 shows a side view of a prosthetic heart valve 6000 having avalve body 6100 and a leaflet clip 6200 disposed in an engagedconfiguration, according to an embodiment. The leaflet clip 6200includes a covering 6210 that defines a passageway 6215 configured toallow blood to flow there-though when the prosthetic heart valve 6000 isbeing delivered to a native heart valve. In this manner, the passageway6215 can allow blood to flow there-through when the leaflet clip 6200 isdisposed in a disengaged “ready state” position (not shown) duringdelivery, thereby limiting and/or reducing potential blood flowrestriction, and enhancing movement and manipulation of the leaflet clip6200 and the valve body 6100 during delivery thereof. Although thepassageway 6215 of the leaflet clip 6200 is shown as oval-shapedaperture, in other embodiments, passageway 6215 can be any suitableshape, size, or configuration, and can include any suitable number ofapertures, windows, passageways or varying porosities. For example, thepassageway 6215 can define multiple distinct passageways (e.g., 2, 3, 4or more). In other embodiments, the passageway 6215 can define multiplepassageways operably coupled to one another (e.g., in fluidcommunication).

FIG. 14 shows a first leaflet clip 7200 a and a second leaflet clip 7200b (referred to collectively as “clips 7200”) having a curved shape,according to an embodiment. The curved shape of the leaflet clips 7200can be configured to facilitate delivery and deployment of the valvebody (not shown) and the leaflet clips 7200. More specifically, theleaflet clips 7200 can be configured to limit or avoid undesirableinterference and/or contact between the leaflet clips 7200 and nativechordae tendineae of a heart. Although shown as having an S-shape, inother embodiments, the leaflet clips 7200 can have any suitable shape tolimit interference with the native chordae tendineae.

FIGS. 15-18 show a prosthetic heart valve 8000 in side view (FIG. 15),in front view (FIG. 16), in detailed view (FIG. 17), and in perspectiveview (FIG. 18), according to an embodiment. The prosthetic heart valve8000 has a valve body 8100, a first leaflet clip 8200 a and a secondleaflet clip 8200 b (referred to collectively as “clips 8200”). Theleaflet clips 8200 are operably coupled to the valve body 8100. Thevalve body 8100 has a native leaflet retention portion 8140 (alsoreferred to herein as “retention portion”) configured to receive anative leaflet and/or the leaflet clips 8200 when the valve body 8100 isdisposed within a native annulus of an atrioventricular valve of aheart. The valve body 8100 further includes a first sealing portion 8150a and a second sealing portion 8150 b (referred to collectively as“sealing portions 8150”), both of which are configured to provide afluid seal between the valve body 8100 and a native leaflet when thenative leaflet is disposed between the leaflet clips 8200 and the valvebody 8100.

The retention portion 8140 can be any suitable size and/or shape, andcan be located at any suitable portion of the valve body 8100. Forexample, the retention portion 8140 can be sized and/or shaped tocorrespond to (e.g., by shape, size, surface design, texture, etc.) aportion of the leaflet clips 8100 and/or the native leaflets. In thismanner, in use, the retention portion 8140 and the leaflet clips 8100can cooperatively function to substantially maintain one or more nativeleaflets when the leaflet clips 8200 are disposed in an engagedconfiguration, i.e., when the leaflet clips 8200 are disposed to capturethe one or more native leaflets between the leaflet clips 8200 and theretention portion 8140 of the valve body 8100 when the valve body 8100is disposed in a native annulus of an atrioventricular valve of a heart.

As best shown in FIGS. 15 and 17, the retention portion 8140 can have adiameter smaller than a diameter of a portion of the valve body 8100proximal to the retention portion 8140. In this manner, the retentionportion 8140 can be configured to receive the leaflet clips 8200 suchthat a diameter of the leaflet clips 8200 (i.e., from an exteriorsurface of the first leaflet clip 8200 a to an exterior surface of thesecond leaflet clip 8200 b) is not larger than the diameter of theportion of the valve body 8100 proximal to the retention portion 8140.Said another way, as shown in FIG. 17, the leaflet clips 8200 define aplane LP, and the portion of the valve body 8100 proximal to theretention portion 8140 defines a plane BP. As shown best in FIG. 17, adistance D1 between the plane LP and a centerline axis A of valve body8100 is less than a distance D2 between the plane BP and the centerlineaxis A. Such a configuration allows for and promotes the sealing by thesealing portions 8150, thereby promoting desirable containment of thenative leaflet between the valve body 8100 and the leaflet clips 8200.In this manner, the sealing portions 8150 and the leaflet clips 8200 arecollectively configured to limit blood flow outside of the prostheticheart valve 8000 and between the atrium and ventricle of the heart.Further, in use, multiple points of contact, i.e., a first point ofcontact (FP) between the leaflet clips 8200, a native leaflet, and thevalve body 8100, and second point of contact (SP) by the sealingportions 8150 and the valve body 8100, promotes sealing between theatrium and ventricle of the heart.

Moreover, contact at the sealing portions 8150 between the valve body8100 and a native leaflet promotes desirable seating of the prostheticheart valve 8000 within the native annulus of the atrioventricularvalve. More specifically, in use, a force applied by the leaflet clips8200 to the native leaflet and the valve body 8100 at the sealingportions 8150 provides a containment force, which promotes sufficientseating of the prosthetic heart valve 8000 within the native annulus ofthe atrioventricular valve.

In some embodiments, as best shown in FIG. 18, the leaflet clips 8200are disposed between, and not in interference with, the chordaetendineae CT within a ventricle of a heart when the valve body 8100 isdisposed within the native annulus of the atrioventricular valve. Inthis manner, the leaflet clips 8200 can transition between variousconfigurations (e.g., between an engaged and disengaged configuration)without undesirable interference with the native chordae tendineae.Referring now to FIG. 19, a prosthetic heart valve system 9000 is shownthat includes a prosthetic valve body 9100, an anchoring tether 9400operably coupled to the valve body 9100, a first leaflet clip 9200 a anda second leaflet clip 9200 b (referred to collectively as “clips 9200”)coupled to the valve body 9100, and a first control element 9300 a and asecond control element 9300 b (referred to collectively as “controlelements 9300”) operably coupled to the first leaflet clip 9200 a andthe second leaflet clip 9200 b, respectively. The leaflet clips 9200 aremovably coupled to the prosthetic valve body 9100 and are configured tobe transitioned between a first configuration in which the prostheticvalve 9000 can be inserted into a heart, and a second configuration inwhich the leaflet clips 9200 are disposed to capture native valveleaflets between the leaflet clips 9200 and the valve body 9100 when thevalve body 9100 is disposed in a native annulus of an atrioventricularvalve of a heart.

The control elements 9300 are operably coupled to the leaflet clips9200. In some embodiments, the control elements 9300 are removablycoupled to the leaflet clips 9200. The first control element 9300 a hasa proximal end 9360 a and a distal end 9370 a. The proximal end 9360 ais configured to be operably coupled to a control portion 9230 a of thefirst leaflet clip 9200 a. Similarly, the second control element 9300 bhas a proximal end 9360 b and a distal end 9370 b. The proximal end 9360b is configured to be operably coupled to a control portion 9230 b ofthe second leaflet clip 9200 b. The proximal ends 9360 a, 9360 b of thecontrol elements 9300 are referred to collectively as “proximal ends9360” and the distal ends 9370 a, 9370 b of the control elements 9300are referred to collectively as “distal ends 9370.” In some embodiments,the proximal ends 9360 are configured to be removably coupled to thecontrol portions 9230, of the leaflet clips 9200. The control elements9300 each have a length sufficient to extend from the leaflet clips9200, through a ventricle of the heart, and out a wall of the ventricle(e.g., through myocardium) when the valve body 9100 is disposed in thenative annulus of the atrioventricular valve of the heart. Said anotherway, the distal ends 9370 of the control elements 9300 are disposedoutside the heart when the proximal ends 9360 are coupled to the leafletclips 9200 and the valve body 9100 is disposed in the native annulus ofthe atrioventricular valve.

As described herein, the control elements 9300 are configured to allow auser to transition the leaflet clips 9200 through variousconfigurations. For example, the control elements 9300 can allow a userto transition the leaflet clips 9200 from their first configuration(disengaged) to their second configuration (engaged) when the valve body9100 is disposed in the native annulus of the atrioventricular valve.More specifically, in use, the user can manipulate the distal ends 9370of the control elements 9300 to manipulate the leaflet clips 9200 in anysuitable manner. For example, the user can move the distal ends 9370 ofthe control elements 9300 distally to transition the leaflet clips 9200distally and dispose the leaflet clips 9200 in a disengaged “readystate.” Further to this example, the user can move the distal ends 9370of the control elements 9300 proximally (or allow the distal ends 9370of the control elements 9300 to move proximally) to transition theleaflet clips 9200 proximally and allow the leaflet clips 9200 tocapture a native valve leaflet between the leaflet clips 9200 and thevalve body 9100.

Moreover, the user can manipulate the leaflet clips 9200 between variouspositions and/or configurations (e.g., engaged, partially engaged,disengaged) via the control elements 9300 any suitable number of times.For example, the user can reposition the leaflet clips 9200 after theleaflet clips 9200 have been transitioned to the engaged position,thereby allowing the user to either capture a native leaflet after afailed attempt at capturing the leaflet, or to re-capture the nativeleaflet.

The anchoring tether 9400 can be the same as or similar to any anchoringtether described in International Patent Application No. PCT/US14/49218,entitled “Epicardial Anchor Devices and Methods,” and InternationalPatent Application No. PCT/US12/50740, entitled “Improved DeliverySystems and Methods for Transcatheter Prosthetic Valves,” thedisclosures of which are incorporated herein by reference in theirentirety. The anchoring tether 9400 is operably coupled to a distal end9120 of the valve body 9100. The anchoring tether 9400 can be used toanchor or secure the prosthetic valve body 9100 when the valve body 9100is disposed in a native annulus of an atrioventricular valve of a heart.Further, the anchoring tether 9400 can be used to position or repositionthe prosthetic valve body 9100 within the heart. The anchoring tether9400 has a length sufficient to extend from the distal end 9120 of thevalve body 9100 through the ventricle of the heart and out the wall ofthe ventricle when the valve body 9100 is disposed in a native annulusof the atrioventricular valve of the heart.

In use, in some embodiments, the valve body 9100 can be delivered to,deployed, and/or disposed within a native annulus of an atrioventricularvalve of a heart when the leaflet clips 9200 are in a disengagedconfiguration. Similarly stated, the leaflet clips 9200 can remain inthe disengaged position until the valve body 9100 is properly seatedwithin the native heart, and/or disposed in a position suitable formanipulation of the leaflet clips 9200. After the valve body 9100 isdisposed in the native annulus of the atrioventricular valve, which canbe verified using fluoroscopy, or any other imaging technique, theleaflet clips 9200 can be deployed in any suitable manner.

In some embodiments, the valve body 9100 can be repositioned to allowfor suitable deployment of the leaflet clips 9200 (e.g., to allowmovement of the leaflet clips 9200 within the ventricle of the heartwithout undesirable interference by a wall of the heart). Similarlystated, the valve body 9100 can be offset from an axis (now shown)defined by a tensioned anchoring tether 9400 before deployment of theone or more of the leaflet clips 9200. For example, the valve body 9100can be canted away from a posterior wall of the heart to allow adequatespace for movement of one of the leaflet clips 9200. In use, once thevalve body 9100 is disposed in a proper position for a user totransition one or more of the leaflet clips 9100 from a disengagedposition to an engaged position, the user can manipulate one of thecontrol elements 9300 to thereby manipulate one of the leaflet clips9200. Once one of the leaflet clips 9200 is transitioned into theengaged position such that it properly captures a native leaflet, thevalve body 9100 can be repositioned to allow for adequate space formovement of another one of the leaflet clips 9200.

Moreover, in use, the valve body 9100 can be repositioned (e.g., offsetfrom the axis defined by the anchoring tether 9400) in any suitablemanner. For example, the anchoring tether 9400 can be manipulatedoutside the heart by a user, thereby resulting in movement or canting ofthe valve body 9100. In some embodiments, an elongate member (not shown;can be similar to elongate member 12350 or any other elongate memberdescribed herein) defining a lumen configured to receive the anchoringtether 9400 can be used to reposition the valve body 9100 to allow forproper deployment of the leaflet clips 9200. For example, in use, afterthe valve body 9100 is seated within the native annulus of theatrioventricular valve, the elongate member (not shown) can beintroduced into the heart and moved proximally towards the distal end9120 of the valve body 9100. In this manner, a user can manipulate adistal end of the elongate member (not shown) to reposition the valvebody 9100, thereby allowing for adequate space for deployment of theleaflet clips 9200. In some embodiments, the elongate member (not shown)can be operably coupled to the distal end 9120 of the valve body 9100 topromote adequate control of the valve body 9100 by the elongate member(or by a user of the elongate member). In some embodiments, a basemember (not shown), defining a tether passageway through which a portionof the anchoring tether 9400 extending from the valve 9100 and outsidethe heart can be received there-through, can be used to assess aposition of and/or reposition the valve body 9100 when the valve body9100 is disposed in the native annulus of an atrioventricular valve. Thebase member (not shown) can be the same as or similar to any of the basemembers described in International Patent Application PCT/US14/49218,entitled “Epicardial Anchor Devices and Methods,” the disclosure ofwhich is incorporated herein by reference in its entirety.

Referring now to FIGS. 20a and 20b , a prosthetic heart valve system10000 is shown that includes a prosthetic valve body 10100, leafletclips 10200, control elements 10300, and an anchoring tether 10400. Thecomponents of the prosthetic heart valve system 10000 (e.g., the valvebody 10100, the leaflet clips 10200, and the control elements 10300) canbe substantially similar to and/or the same as the components of theprosthetic heart valve system 9000 described above with reference toFIG. 19. Thus, the valve body 10100, the leaflet clips 10200, and thecontrol elements 10300 are not described in further detail herein andshould be considered the same as the valve body 9100, the leaflet clips9200, and the control elements 9300 unless expressly stated otherwise.As described herein, the anchoring tether 10400 can be used to anchor orsecure the prosthetic valve body 10100 in the same or similar manner asdescribed above for previous embodiments. As shown in FIG. 20b , theanchoring tether 10400 defines a lumen 10410 through which the controlelements 10300 can be disposed. The lumen 10410 has a proximal end 10412and a distal end 10414, and can be any suitable size and shapeconfigured to receive the control elements 10300. In some embodiments,additional lumens 10410 (not shown) can be included in the anchoringtether 10400. For example, the anchoring tether 10400 can define a firstlumen 10410 a configured to receive a first control element 10300 a, anda second lumen 10410 b configured to receive a second control element10300 b.

In use, the control elements 10300 can be disposed in the lumen 10410 ofthe anchoring tether 10400. More specifically, the control elements10300 can be routed into the proximal end 10412 of the anchoring tether10400 and out of the distal end 10414 of the anchoring tether 10400 whenthe valve body 10100 is disposed within a native annulus of anatrioventricular valve of a heart. Such a configuration consolidates thecontrol elements 10300 and the anchoring tether 10400 thereby reducingor limiting the footprint and friction of the control elements 10300 andthe anchoring tether 10400 within the ventricle of the heart. In thismanner, undesirable interference or contact between the control elements10300 and the anchoring tether 10400, and native chordae tendineae ofthe heart can be reduced or limited.

Moreover, in use, the anchoring tether 10400 and the control elements10300 are partially disposed outside the heart such that they can besecured, manipulated, or otherwise used by a user. More specifically, asshown in FIG. 20a , the anchoring tether 10400 and the control elements10300 extend through a puncture site PS of a wall V of a heart. Thus,disposing the control elements 10300 within the anchoring tether 10400can reduce or limit the size of the puncture site PS, thereby reducing apatient's recovery time associated with the puncture site PS.

FIGS. 21a and 21b show an embodiment of a prosthetic heart valve system11000 that includes an elongate member 11350 having a first end 11352configured to be disposed in a ventricle of the heart during deploymentof the valve body 11100, and a second end 11354 configured to extendoutside the heart. The prosthetic heart valve system 11000 includes aprosthetic valve body 11100, an anchoring tether 11400, leaflet clips11200, and control elements 11300, which can be configured the same asor similar to the prosthetic valve body 9100, the leaflet clips 9200,the control elements 9300, and the anchoring tether 9400, respectively,described above with reference to FIG. 19. Thus, the valve body 11100,the leaflet clips 11200, the control elements 11300, and the anchoringtether 11400 are not described in further detail herein and should beconsidered the same as the valve body 9100, the leaflet clips 9200, thecontrol elements 9300, and the anchoring tether 9400 unless expresslystated otherwise.

The elongate member 11350 defines an anchoring tether lumen 11356, afirst control element lumen 11358 a and a second control element lumen11358 b (referred to collectively as “control element lumens 11358”),and a first leaflet clip attachment portion 11380 a and a second leafletclip attachment portion 11380 b (referred to collectively as “leafletclip attachment portions 11380”). The tether lumen 11356 can be anysuitable shape or size configured to receive at least a portion of theanchoring tether 11400. The control element lumen 11358 can be anysuitable shape or size configured to receive at least a portion of thecontrol elements 11300. The leaflet clip attachment portions 11380 canbe any suitable size or shape configured to receive, and be operably andremovably coupled to a control portion 11230 a of the first leaflet clip11200 a and a control portion 11230 b of the second leaflet clip 11200 b(referred to collectively as “control portions 11230”).

In use, the anchoring tether 11400 is disposed in the anchoring tetherlumen 11356 and extends out the second end 11354 of the elongate member11350. Similarly, the control elements 11300 are disposed in the controlelement lumens 11358 and extend out the second end 11354 of the elongatemember 11350. Further, the leaflet clips 11200 can be held in adisengaged “ready state” position (first configuration) via the leafletclips attachment portion 11360 of the elongate member 11350 and thecontrol elements 11300. More specifically, in the first configuration,as shown in FIG. 21a , the control portions 11230 of the leaflet clips11200 are removably coupled to the elongate member 11356 and the controlelements 11300. Further, the control elements 11300 extend from thecontrol portions 11230 to the second end 11354 of the elongate member11356 and outside the heart.

To transition the leaflet clips 11200 from the disengaged configuration(first position) to the engaged configuration (second position; notshown), the control elements 11300 can be decoupled from the leafletclips 11200, thereby releasing the leaflet clips 11200 and allowing theleaflet clips 1200 to transition to the engaged configuration. Thecontrol elements 11300 can be decoupled from the leaflet clips 11200 inany suitable manner. For example, a portion of control element 11300 canbe moved distally (e.g., pulled by a user), resulting in separation ofthe control elements from the leaflet clips 11200. In this manner, theleaflet clips 11200 can be transitioned from the first configuration tothe second configuration, for example, due to shape memory properties ofthe leaflet clips 11200, when the control elements 11300 are decoupledfrom the leaflet clips 11200. In some embodiments, the leaflet clips11200 can be transitioned from the first configuration to the secondconfiguration in response to movement of the elongate member 11350. Forexample, a user can move the elongate member 11350 distally such thatthe leaflet clips 11200 are separated from, or otherwise no longerdisposed within, the leaflet clip attachment portion 11360. In thismanner, the leaflet clips 11200 can be released from the leaflet clipattachment portion 11360, such that the leaflet clips 11200 are nolonger contained or otherwise restricted in the first configuration bythe elongate member 11350. In some embodiments, after the leaflet clips11200 are decoupled from the elongate member 11350, the leaflet clipscan transition, without manipulation by the control elements 11300, fromthe disengaged configuration to the engaged configuration. In otherembodiments, after the leaflet clips 11200 are decoupled from theelongate member 11350, the leaflet clips can be manipulated betweenconfigurations by the control elements 11300. In the secondconfiguration, the leaflet clips 11200 are disposed to capture one ormore native valve leaflets between the leaflet clips 11200 and the valvebody 11100 when the valve body 11100 is disposed in a native annulus ofan atrioventricular valve.

Although the elongate member 11350 defines control element lumens 11358,in other embodiments, the elongate member 11350 can instead, or inaddition, define control element channels (not shown) along the outsideof the elongate member 11350. In this manner, the control elementchannels can function the same and/or similar to the control elementlumens 11358 described herein.

Referring now to FIGS. 22a-23b , a prosthetic heart valve system 12000is shown that includes a prosthetic valve body 12100, a first leafletclip 12200 a including a control portion 12230 a and a second leafletclip 12200 b including a control portion 12230 b (referred tocollectively as “leaflet clips 12200”), a first control element 12300 aand a second control element 12300 b (referred to collectively as“control elements 12300”), anchoring tether 12400, and an elongatemember 12350. The components of the prosthetic heart valve system 12000(e.g., the valve body 12100, the leaflet clips 12200, and the controlelements 12300) can be substantially similar to and/or the same as thecomponents of the prosthetic heart valve system 11000 described abovewith reference to FIGS. 21a and 21b . Thus the valve body 12100, theleaflet clips 12200, and the control elements 12300 are not described infurther detail herein and should be considered the same as the valvebody 11100, the leaflet clips 11200, and the control elements 11300unless expressly stated otherwise. As described herein the anchoringtether 12400 can be used to anchor or secure the prosthetic heart valvebody 12100 in the same or similar manner as described above for previousembodiments.

The elongate member 12350 defines a first control element lumen 12358 a,a second control element lumen 12358 b, a third control element lumen12358 c, and a fourth control element lumen 12358 d (referred tocollectively as “control element lumens 12358,” all through which thecontrol elements 12300 can be disposed, and a tether lumen 12356configured to receive the anchoring tether 12400. The control elementlumens 12358 have proximal ends 12412 and distal ends 12414, and can beany suitable size and shape configured to receive at least a portion ofthe control elements 12300. In some embodiments, additional lumens (notshown) can be included in the elongate member 12350, for example, toaccommodate additional control elements.

In use, the control elements 12300 can be disposed in the controlelement lumens 12358. More specifically, the first control element 12300a can be routed proximally through the first control element lumen 12358a from its distal end 12414 a (not shown) to its proximal end 12412 a(not shown), operably coupled to the control portion 12230 a of thefirst leaflet clip 12200 a (e.g., looped through an aperture defined bythe control portion 12230 a), then routed distally through the secondcontrol element lumen 12358 b from its proximal end 12412 b to itsdistal end 12414 b and extending outside the heart. In this manner, auser can manipulate the first leaflet clip 12200 a, and subsequentlyremove the first control element from the leaflet clip 12200 a and thepatient's body. Similarly, the second control element 12300 b can berouted proximally through the third control element lumen 12358 c fromits distal end 12414 c to its proximal end 12412 c, operably coupled tothe control portion 12230 b of the second leaflet clip 12200 b (e.g.,looped through an aperture defined by the control portion 12230 b), thenrouted distally through the fourth control element lumen 12358 d fromits proximal end 12412 d to its distal end 12414 d and extending outsidethe heart. In this manner, a user can independently manipulate thesecond leaflet clip 12200 a, and subsequently remove the first controlelement from the leaflet clip 12200 a and the patient's body.

Moreover, in use, the control elements 12300 can be moved distallyoutside the heart such that the leaflet clips 12200 are transitionedinto a disengaged “ready state,” shown best in FIG. 22a . Further, thecontrol elements 12300 can be moved proximally (e.g., released) fromoutside the heart such that the leaflet clips 12200 are transitionedinto an engaged configuration, shown best in FIG. 23a . After theleaflet clips 12200 are transitioned into the engaged configuration, thepositioning of the leaflet clips can be verified using fluoroscopy, orany other imaging technique. If any of the leaflet clips 12200 are notproperly positioned (e.g., one or more leaflet clips 12200 have notadequately captured a native valve leaflet), one or more controlelements 12300 can be moved distally outside the heart to transition theleaflet clip(s) 12200 back to the disengaged configuration to allowrepositioning of the valve body 12100 or additional attempts atcapturing the native valve leaflets.

After the leaflet clips 12200 have captured the native leaflets andtheir positioning verified, the control elements 12300 can be removedfrom the ventricle of the heart by pulling a first end of the controlelements 12300, and releasing a second end of the control elements12300. For example, the control elements 12300 (e.g., sutures) caninclude four free ends disposed outside the heart. To decouple thecontrol elements 12300 from the leaflet clips 12200, two free ends fromthe four free ends can be moved distally outside the heart. In thismanner, the remaining two free ends will translate proximally throughtwo of the control element lumens 12358, and then distally through thetwo remaining control element lumens 12358, thereby allowing fordecoupling of the control elements 12300 from the leaflet clips 12200and removal of the control elements 12300 from the ventricle of thenative heart valve.

In other embodiments, the prosthetic heart valve system 12000 caninclude additional control elements (not shown). For example, theprosthetic heart valve system 1200 can include the first control element12300 a, the second control element 12300 b, a third control element,and a fourth control element. In such embodiments, the control elementscan include four distinct elements (e.g., four distinct sutures).Further, the first leaflet clip 12200 a can include a first controlportion 12230 a and a second control portion. Similarly, the secondleaflet clip 12200 b can include a first control portion 12230 b and asecond control portion. The first control portion 12230 a and the secondcontrol portion of the first leaflet clip 12200 a can be configured tobe operably and removably coupled to the first control element 12300 aand the third control element, respectively. Similarly, the firstcontrol portion 12230 b and the second control portion of the secondleaflet clip 12200 b can be configured to be operably and removablycoupled to the second control element 12300 b and the fourth controlelement, respectively. In use, the control elements described in thisembodiment can be routed individually from the leaflet clips 12200through the control element lumens 11358, and outside the heart.

Referring now to FIGS. 24-26 d, a prosthetic heart valve system 13000 isshown that includes a prosthetic valve body 13100, leaflet clips 13200,control elements 13300, an elongate member 13350, and an anchoringtether 13400. The components of the prosthetic heart valve system 13000(e.g., the valve body 13100, the leaflet clips 13200, the elongatemember 13350, and the control elements 13300) can be substantiallysimilar to and/or the same as the components of the prosthetic heartvalve system 12000 described above with reference to FIGS. 23a and 23b .Thus, the valve body 13100, the leaflet clips 13200, the elongate member13350, and the control elements 13300 are not described in furtherdetail herein and should be considered the same as the valve body 12100,the leaflet clips 13200, and the control elements 12300 unless expresslystated otherwise. As described herein the anchoring tether 13400 can beused to anchor or secure the prosthetic valve body 13100 in the same orsimilar manner as described above for previous embodiments.

The elongate member 13350 has a proximal end 13352 configured to bedisposed in a ventricle of the heart during deployment of the valve body13100, and a distal end 13354 configured to extend outside the heart andbe operably coupled to a tubular body 13600. The elongate member 13350can be coupled to the tubular body 13600 in any suitable manner (e.g.,using any suitable fastener or fastening method, a screw, wire, aninterference fit, laser welding, etc.). For example, as shown in FIG.24, the elongate member 13350 can receive a proximal end 13620 of thetubular body 13600. As best shown in FIGS. 25a and 25b , the elongatemember 13350 defines a first control element lumen 13358 a, a secondcontrol element lumen 13358 b, a third control element lumen 13358 c,and a fourth control element lumen 13358 d (referred to collectively as“control element lumens 13358”) all through which the control elements13300 can be disposed. The elongate member 13350 further defines atether lumen 13356 there-through configured to receive the anchoringtether 13400. The control element lumens 13358 can be any suitable sizeand shape configured to receive at least a portion of the controlelements 13300. In some embodiments, additional lumens (not shown) canbe included in the elongate member 13350.

As best shown in FIG. 26a , each of the control elements 13300 arecoupled to a mandrel 13700. The tubular body 13600 has a proximal end13620 and a distal end 13630, and defines a first mandrel slot 13610 aat a first radial location, and a second mandrel slot 13610 b and asecond radial location, and a lumen 13650 extending from the proximalend 13620 to the distal end 13630. The first and second slots 13610 a,13610 b are referred to collectively as “mandrel slots 13610” and areconfigured to receive the mandrels 13700 in any suitable manner (e.g., akeyed joint) to removably couple the control elements 13300 to thetubular body 13600 (FIG. 26d ). Moreover, a retaining element (notshown) can be disposed on the tubular body 13600 to retain the mandrels13700 in the mandrel slots 13610 until the control elements 13300 areready to be used to deploy the leaflet clips 13200.

In some embodiments, some or all of the components described herein(e.g., the elongate member 13350, the tubular body 13600, etc.) can beprovided separately and joined together in preparation for delivery anddeployment of the prosthetic valve 13000 (referred to as “loading thevalve”). For example, to load the valve, the elongate member 13350 canbe slidably disposed about the anchoring tether 13400. Similarly stated,the anchoring tether 13400 can be disposed in the tether lumen 13356 ofthe elongate member 13350. The proximal end 13620 of the tubular member13600 can be coupled to the distal end 13354 of the elongate member13350 such that the anchoring tether 13400 extends from the proximal end13352 of the elongate member 13350, through the tether lumen 13356 ofthe elongate member 13350, and continuing through the tether lumen 13650of the tubular member 13600 from its proximal end 13620 to its distalend 13610. A first end of each control element 13300 can be coupled toeach mandrel 13700 and a second end of each control element 13300 can becoupled to any suitable location within the elongate member 13350. Forexample, as best shown in FIG. 25a , one end of the control element13300 can be disposed in and coupled to the control element lumen 13358a of the elongate member 13350, while the other end of the controlelement 13300 can be coupled to the mandrel 13700. Further to thisexample, the mandrel 13700 can be routed distally through the controlportion 13200 a of the leaflet clip 13200 a, and then proximally throughthe control element lumen 13358 b from the proximal end 13352 of theelongate member 13350 to the distal end 13354 of the elongate member13350, and then into the mandrel slot 13610 a. In this manner, eachmandrel 13700 can be operably coupled to a leaflet clip 13200, and canbe disposed in the mandrel slots 13610 of the tubular member 13600 untilthe control elements 13300 are ready to be used to deploy the leafletclips 13200.

In use, each mandrel 13700 can be released from their respective mandrelslots 13610 in any suitable manner (e.g., both mandrels 13700 can bereleased substantially simultaneously, or at distinct times). In thismanner, the leaflet clips 13200 can be manipulated together orseparately. Once released, each mandrel 13700 can be routed through acontrol element lumen 13358 from the distal end 13354 to the proximalend 13352 of the elongate member 13350. For example, the elongate member13350 can be pulled distally such that each mandrel 13700 translatesthrough a control element lumen 13358 and out from the proximal end13352 of the elongate member 13350. As the mandrels 13700 translateproximally towards the proximal end 13352 of the elongate member 13350,the leaflet clips 13200 can transition positions between a disengagedposition and an engaged position, thereby capturing one or more nativeleaflets. After the leaflet clips 13200 are disposed in a suitableposition (e.g., after leaflet capture), the control elements 13200,elongate member 13350, tubular member 13600, and mandrels 13700 can bedecoupled from the valve body 13100 and removed from a patient's heart.During removal, in some embodiments, the mandrels 13700 can be routedthrough the control portions 13200 of the leaflet clips 13200. In otherembodiments, the mandrels 13700 can be decoupled from the controlelements 13300 (e.g., cut away).

Referring now to FIG. 27, a leaflet clip retrieval member 14800 (alsoreferred to as “retrieval member 14800”) is shown that includes anelongate member 14810 having a proximal end 14820, a distal end 14830,and defining a tether lumen 14840 there-through. The retrieval member14800 also includes a leaflet contact portion 14850 (also referred to as“contact portion 14850) coupled to, or disposed at, the proximal end14820 of the elongate member 14810. In some embodiments, the elongatemember 14810 and the contact portion 14850 can be monolithicallyconstructed. In other embodiments, the elongate member 14810 and thecontact portion 14850 can be formed separately and then joined together(e.g., using any suitable fastener or fastening method, such as a screw,a wire, an interference fit, laser welding, etc.). In some embodiments,a portion of the contact portion 14850 can be disposed in the elongatemember 14810. For example, the elongate member 14810 can define acontact portion lumen (not shown) configured to receive at least aportion of the contact portion 14850. The contact portion lumen (notshown) can be distinct from the tether lumen 14840.

The retrieval member 14800 is configured to manipulate one or moreleaflet clips (e.g., any of the leaflet clips described in any of theembodiments herein). Further, the retrieval member 14800 is configuredto be inserted through a puncture site (not shown) in a wall of a heart(not shown), translate proximally towards a prosthetic heart valve(e.g., any of the prosthetic heart valves described in any of theembodiments herein) such that the contact portion 14850 can be coupledto a leaflet clip to manipulate a leaflet clip. In this manner, theretrieval member 14800 can be configured to manipulate a leaflet clipsfrom an engaged configuration to a disengaged configuration. In use,during retrieval of a prosthetic heart valve from within a nativeannulus of an atrioventricular valve of a heart, the retrieval member14800 can manipulate the leaflet clips such that the leaflet clips arein a favorable position for removal from the heart (e.g., without anative leaflet disposed between the leaflet clip and the prostheticvalve body). The contact portion 14850 of the retrieval member 14800 canbe any suitable size, shape or configuration suitable to attach to andmanipulate a leaflet clip. For example, the contact portion 14850 can behook-shaped and configured to be operably coupled to a leaflet clip(e.g., a control portion of a leaflet clip). As another example, thecontact portion 14850 can be configured to pierce a covering of aleaflet clip, and thereby grab the leaflet clip for subsequentmanipulation thereof.

The tether lumen 14840 can be any suitable size, shape or configurationsuitable to receive an anchoring tether (e.g., any of the anchoringtethers described in any of the embodiments herein). In use, theretrieval member 14800 can be moved proximally towards a prostheticvalve body disposed in a native annulus of an atrioventricular valve.More specifically, the retrieval member 14800 can be moved along ananchoring tether (not shown) disposed within the tether lumen 14840 ofthe elongate member 14810. In this manner, the anchoring tether canserve as a guide for the retrieval member 14800. During removal of theprosthetic valve, a user can translate the retrieval member 14800proximally along the anchoring tether, thereby allowing the contactportion 14850 to contact and manipulate a leaflet clip (e.g., disengagethe leaflet clip), and then translate the retrieval member 14800distally such that the retrieval member 14800 can be removed from theheart.

Referring now to FIGS. 28 and 29, a prosthetic heart valve system 15000is shown that includes a prosthetic valve body 15100, an anchoringtether 15400 operably coupled to the valve body 15100, a first leafletclip 15200 a and a second leaflet clip 15200 b (referred to collectivelyas “clips 15200”) coupled to the valve body 15100, a control element15300 operably coupled to the first leaflet clip 15200 a and the secondleaflet clip 15200 b. The leaflet clips 15200 are movably coupled to theprosthetic valve body 15100 and are configured to be transitionedbetween a first configuration in which the prosthetic valve 15000 can beinserted into a heart, and a second configuration in which the leafletclips 15200 are disposed to capture native valve leaflets between theleaflet clips 15200 and the valve body 15100 when the valve body 15100is disposed in a native annulus of an atrioventricular valve of a heart.

The control element 15300 is operably and removably coupled to theleaflet clips 15200, and configured to be slidably disposed about theanchoring tether 15400. The control element 15200 defines a lumen 15210there-through configured to receive the anchoring tether 15400 and theleaflet clips 15200. As described herein the control element 15300 isconfigured to allow a user to transition the leaflet clips 15200 throughvarious positions. For example, the control element 15300 can allow auser to transition the leaflet clips 15200 from their firstconfiguration (disengaged), as shown in FIG. 28, to their secondconfiguration (engaged), as shown in FIG. 29, when the valve body 15100is disposed in the native annulus of the atrioventricular valve. Morespecifically, in use, the user can manipulate the control element 15300to manipulate the leaflet clips 15200 in any suitable manner. Forexample, the user can move the control element 15300 distally totransition the leaflet clips 15200 from their disengaged configurationto their engaged configuration, thereby allowing the leaflet clips 15200to capture a native valve leaflet between the leaflet clips 15200 andthe valve body 15100. More specifically, the leaflet clips 15200 can bein a deformed, disengaged configuration when disposed within the lumen15210 of the control element 15200, for example, during delivery of theprosthetic heart valve 15000. To capture the native leaflets, thecontrol element 15200 can be moved distally, or otherwise separated fromthe leaflet clips 15200, thereby allowing the leaflet clips 15200 returnto their undeformed, engaged configuration, and allowing the leafletclips 15200 to capture a native valve leaflet between the leaflet clips15200 and the valve body 15100. In some embodiments, the prostheticheart valve 15000 can include additional control elements (e.g., controlelements 9300, or any other suitable control element described herein).

Referring now to FIGS. 30 and 31, a prosthetic heart valve system 16000is shown that includes a prosthetic valve body 16100, an anchoringtether 16400 operably coupled to the valve body 16100, a control element16300 operably coupled to the anchoring tether 16400, and a firstleaflet clip 16200 a and a second leaflet clip 16200 b (referred tocollectively as “clips 16200”) coupled to the control element 16300. Theleaflet clips 16200 are movably coupled to the control element 16300 andare configured to be transitioned between a first configuration (FIG.30) in which the leaflet clips are not in contact with native leafletclips, and a second configuration (FIG. 31) in which the leaflet clips16200 are disposed to capture native valve leaflets between the leafletclips 16200 and the valve body 16100 when the valve body 16100 isdisposed in a native annulus of an atrioventricular valve of a heart.

The control element 16300 is operably the leaflet clips 16200, andconfigured to be slidably disposed about the anchoring tether 16400. Thecontrol element 16300 defines a lumen 16210 there-through configured toreceive the anchoring tether 16400. As described herein the controlelement 16300 is configured to allow a user to transition the leafletclips 16200 through various positions. For example, the control element16300 can allow a user to transition the leaflet clips 16200 from theirfirst configuration (disengaged), as shown in FIG. 30, to their secondconfiguration (engaged), as shown in FIG. 31, when the valve body 16100is disposed in the native annulus of the atrioventricular valve. Morespecifically, in use, the user can manipulate the control element 16300to manipulate the leaflet clips 16200 in any suitable manner. Forexample, the user can move the control element 16300 distally totransition the leaflet clips 16200 from their disengaged configurationto their engaged configuration, thereby allowing the leaflet clips 16200to capture a native valve leaflet (not shown) between the leaflet clips16200 and the valve body 16100. In use, the leaflet clips 16200 can bein an undeformed, disengaged configuration when disposed within theatrium of a heart valve, for example, during delivery of the prostheticheart valve 16000. To capture the native leaflets, the control element16200 can be moved distally to allow the leaflet clips 16200 to engageone or more native leaflets (not shown) such that the leaflet clips16200 can capture a native valve leaflet between the leaflet clips 16200and the valve body 16100. In some embodiments, the control element 16300and the leaflet clips 16200 can be delivered to the native valvesubstantially simultaneously with delivery of the prosthetic valve body16100 to the native annulus of the valve. In other embodiments, thecontrol element 16300 and the leaflet clips can be delivered to thenative valve subsequent to delivery and/or seating of the prostheticvalve body 16100 within the native annulus of the valve.

In some embodiments, the prosthetic heart valve 16000 can includeadditional control elements (e.g., control elements 9300, or any othersuitable control element described herein). For example, referring nowto FIGS. 32a and 32b , in addition to control element 16300 (referred toin this example as first control element 16300 a), the prosthetic valve16000 can include a second control element 16300 b operably coupled tothe second leaflet clip 16200 b, and configured to manipulate the secondleaflet clip 16200 b in any suitable manner (e.g., between engaged,disengaged, deformed, and undeformed configurations). In someembodiments, the second control element 16300 b can be removably coupledto the second leaflet clip 16200 b. In some embodiments, the prostheticvalve 16000 can include a third control element (not shown) operablycoupled to the first leaflet clip 16200 a, and configured to manipulatethe first leaflet clip 16200 a in any suitable manner (e.g., betweenengaged, disengaged, deformed, and undeformed configurations).

Referring now also to FIG. 32b , the second leaflet clip 16200 b isshown coupled to the second control element 16300 b. The second leafletclip 16200 b defines a first control portion lumen 16230 a and a secondcontrol portion lumen 16230 b (referred to collectively as “controlportion lumens 16230”). The control portion lumens 16230 are configuredto receive a portion of the second control element 16300 b. In use, afirst portion 16310 a of the second control element 16300 b can berouted through the first control portion lumen 16230 a, and a secondportion 16310 b of the second control element 16300 b can be routedthrough the second control portion lumen 16230 b. In this manner, inuse, the first portion 16310 a and the second portion 16310 b can becollectively manipulated to manipulate the second leaflet clip 16200 bbetween various positions and/or configurations. Further, to decouplethe second control element 16300 b from the second leaflet clip 16200 b,the first portion 16310 a of the second control element 16300 b can bemoved through the first control portion lumen 16230 a and the secondcontrol portion lumen 16230 a distance sufficient to remove the secondelement 16300 b from both the lumen 16230 a and the lumen 16230 b.

Referring now to FIGS. 33a -34, a prosthetic heart valve system 17000 isshown that includes a prosthetic valve body 17100 having a leaflet clipdelivery portion 17110, an anchoring tether 17400 operably coupled tothe valve body 17100, a control element (not shown) optionally operablycoupled to the anchoring tether 17400, and a first leaflet clip 17200 aand a second leaflet clip 17200 b (referred to collectively as “clips17200”) operably coupled to the control element (not shown) and movablyand slideably coupled to the leaflet clip delivery portion 17110. Theleaflet clips 17200 are configured to be transitioned between a firstconfiguration (FIG. 33a ) in which the leaflet clips 17200 are not incontact with native leaflet clips, and a second configuration (FIG. 33b) in which the leaflet clips 17200 are disposed to capture native valveleaflets between the leaflet clips 17200 and the valve body 17100 whenthe valve body 17100 is disposed in a native annulus of anatrioventricular valve of a heart.

The leaflet clips 17200 are configured to transition between adisengaged configuration (FIG. 33a ) and an engaged configuration (FIG.33b ). In use, the leaflet clips 17200 can be translated betweenconfigurations via the leaflet clip delivery portion 17110. In thismanner, the leaflet clips 17200 can transition distally from thedisengaged configuration (FIG. 33a ) to the engaged configuration (FIG.33b ), thereby allowing the leaflet clips 17200 to capture a nativevalve leaflet NL between the leaflet clips 17200 and the valve body17100.

Referring now to FIG. 34, the leaflet clip 17200 a is shown, accordinglyto another embodiment. The leaflet clip 17200 a has a fork-like orclaw-like shape configured to capture a native leaflet in a volume Vdefined therein. For example, the leaflet clip 17200 a can be configuredto receive a portion of a native leaflet NL and a portion of the valvebody 17100. In this manner, the leaflet clip 17200 can secure the nativeleaflet NL between the leaflet clip 17200 and the valve body 17100. Inuse, as described herein, the leaflet clip 17200 a can be disposed inthe engaged configuration such that the native leaflet NL and a portionof the valve body 17100 are disposed in volume V. In some embodiments,an interior portion of the leaflet clip 17200 a can have any suitableconfiguration (e.g., any suitable surface design) suitable to receiveand/or retain a native leaflet when the leaflet clip 17200 a is disposedin an engaged configuration.

While various embodiments have been particularly shown and described,various changes in form and details may be made. While embodiments havebeen described above, it should be understood that they have beenpresented by way of example only, and not limitation. Although variousembodiments have been described as having particular features and/orcombinations of components, other embodiments are possible having anycombination or sub-combination of any features and/or components fromany of the embodiments described herein. Moreover, any suitablecombination of components described herein can be physically and/oroperably coupled together to form prosthetic heart valve with leafletclips configured, for example, to capture native valve leaflets andprovide an improved seal between the prosthetic heart valve and thenative valve annulus.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different from the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selecteddepending on native valve annulus size and/or native valve leaflet sizeor position.

Where methods and/or events described above indicate certain eventsand/or procedures occurring in certain order, the ordering of certainevents and/or procedures may be modified. Additionally, certain eventsand/or procedures may be performed concurrently in a parallel processwhen possible, as well as performed sequentially as described above.

Always use the style PATAPPPAR for paragraph numbering from[0001]-[0099].

There should be no hyperlinks in your application.

The document number MUST NOT APPEAR on any page of your application.

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Always use the style 100 for paragraph numbering for paragraphsnumbering [0100] and above. The final paragraph of the applicationshould be as follows:

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. A leaflet clip retrieval apparatus, comprising: an elongate memberhaving a leading end and a trailing end, the elongate member defining atether lumen extending between the leading end and the trailing end, thetether lumen sized and configured to receive an anchoring tetherattached to a prosthetic heart valve implanted in a native annulus of anatrioventricular valve of a heart; and a leaflet contact portionextending from the leading end of the elongate member and configured totransition a leaflet clip coupled to the prosthetic heart valve from afirst configuration in which the leaflet clip is directly engaged with anative leaflet to a second configuration in which the leaflet clip isdisengaged from the native leaflet.
 2. The leaflet clip retrievalapparatus of claim 1, wherein the leaflet contact portion ishook-shaped.
 3. The leaflet clip retrieval apparatus of claim 1, whereinthe leaflet contact portion is configured to pierce a covering of theleaflet clip.
 4. The leaflet clip retrieval apparatus of claim 1,wherein the elongate member further defines a leaflet contact portionlumen.
 5. The leaflet clip retrieval apparatus of claim 4, wherein theleaflet contact portion lumen is radially spaced from the tether lumen.6. The leaflet clip retrieval apparatus of claim 5, wherein the leafletcontact portion is at least partially disposed within the leafletcontact portion lumen.
 7. The leaflet clip retrieval apparatus of claim1, wherein the leaflet contact portion and the elongate member aremonolithically constructed.
 8. A system, comprising: a prosthetic heartvalve including a collapsible and expandable stent, a valve assemblydisposed within the stent, a leaflet clip coupled to the stent and ananchoring tether attached to the stent; and a retrieval apparatus,comprising: an elongate member having a leading end, a trailing end anda tether lumen extending between the leading end and the trailing end;and a leaflet contact portion extending from the leading end of theelongate member, the leaflet contact portion configured to transitionthe leaflet clip of the prosthetic heart valve from a firstconfiguration in which the leaflet clip is directly engaged with anative leaflet to a second configuration in which the leaflet clip isdisengaged from the native leaflet.
 9. The system of claim 8, whereinthe tether lumen of the elongate member is sized and configured toreceive the tether of the prosthetic heart valve.
 10. The system ofclaim 9, wherein the elongate member of the retrieval apparatus isslidable over the tether of the prosthetic heart valve.
 11. The systemof claim 8, wherein the leaflet contact portion includes a hook capableof piercing a covering of the leaflet clip.
 12. The system of claim 11,wherein the hook is configured to grasp the leaflet clip fortransitioning the leaflet clip from the first configuration to thesecond configuration.
 13. The system of claim 8, wherein the elongatemember further defines a leaflet contact portion lumen and the leafletcontact portion lumen is radially spaced from the tether lumen.
 14. Thesystem of claim 13, wherein the leaflet contact portion is at leastpartially disposed within the leaflet contact portion lumen.
 15. Amethod of retrieving a prosthetic heart valve from a nativeatrioventricular valve of a patient, the prosthetic heart valveincluding a collapsible and expandable stent, a valve assembly disposedwithin the stent, a leaflet clip coupled to the stent and an anchoringtether attached to the stent, the method comprising: inserting aretrieval apparatus into the heart of the patient, the retrievalapparatus including an elongate member having a leading end, a trailingend and a tether lumen extending between the leading end and thetrailing end, and a leaflet contact portion extending from the leadingend of the elongate member; engaging the leaflet contact portion of theretrieval apparatus with the leaflet clip of the prosthetic heart valve;and moving the leaflet clip from a first configuration in which theleaflet clip is engaged with a native leaflet to a second configurationin which the leaflet clip is disengaged from the native leaflet.
 16. Themethod of claim 15, further comprising: inserting the tether of theprosthetic heart valve into the tether lumen of the elongate member; andtranslating the elongate member over the tether of the prosthetic heartvalve and toward the prosthetic heart valve.
 17. The method of claim 15,further comprising: piercing a covering of the leaflet clip with theleaflet contact portion of the retrieval apparatus.
 18. The method ofclaim 15, wherein moving the leaflet clip from the first configurationto the second configuration includes retracting the elongate member ofthe retrieval apparatus while the leaflet contact portion is engagedwith the leaflet clip.
 19. The method of claim 15, wherein the leafletclip is curled in the first configuration and substantially elongated inthe second configuration.
 20. The method of claim 15, furthercomprising: removing the prosthetic heart valve from the nativeatrioventricular valve of the patient while the leaflet clip is in thesecond configuration; and removing the retrieval apparatus from theheart of the patient.